Pilot Study of Virtual Reality for Providing Exposure Therapy to Children

Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders

Drs. from the Mayo Clinic Rochester will plan and execute a feasibility study of the phase I prototype version of the Virtual Reality exposure therapy system. Dr. X, who has significant experience in evaluating patient experiences and opinions of technologies intended to change behavior, will oversee a qualitative study to examine the prototype system. Twenty children with generalized anxiety disorder with perfectionism who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Other: Pilot Virtual Reality

Detailed Description

Twenty children with generalized anxiety disorder (perfectionism) who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC) using purposive sampling methods. Each patient will participate in a single (up to) 2-hour visit, allowing for breaks as needed. Staff from Mayo Clinic HealthCare Policy & Research experienced in qualitative data analysis and not involved with the patients' medical care or development of the prototype system will conduct the study visits. During the first 30 minutes the patient and parent will be introduced to the Virtual Reality system and the rationale for this feasibility study. Next, a therapist from the PADC, all of whom are experienced exposure therapists, will lead the patient through exposure exercises using the Virtual Reality system for up to 30 minutes. During the next period, up to 30 minutes, the therapist will go to a different room and the patient, with support from their parent, will complete exposure exercises using the Virtual Reality system that the therapist directed them to complete. During the exposures the interviewer will observe, code and record the patient's interaction with the Virtual Reality system. The data from the Virtual Reality system will be automatically transmitted to a cloud service running on a local laptop to study the effectiveness of the system's automatic logging capabilities. For the remaining time (up to 30 minutes) the interviewer will interview the patient about his or her experience with the Virtual Reality system and then will ask for observations and opinions from the parent.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of Generalized Anxiety Disorder with perfectionism and have received less than three treatment sessions

Exclusion Criteria:

• too young to safely and effectively participate with the study materials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilot virtual reality; Children with anxiety will have a single visit to test the virtual reality system and measure its affects on their anxiety ratings.	Other: Pilot Virtual Reality; Exposure to a virtual reality vignette with anxiety rating to support exposure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative response to the system as assessed by observation while using the system and interview following use.	Twenty participants will provide qualitative data about their experience using the system.	through study completion, an average of one day study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety as assessed by the Subjective Units of Distress Scale	Anxiety for each of the twenty participants will be assessed using SUDS prior to and after each time repeating the exposure. Participants will self-select how many times to repeat the exposure during the one day study visit.	through study completion, an average of one day study visit

Collaborators and Investigators

• Sponsor: Minnesota HealthSolutions
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Sara Seifert, MPH, Minnesota HealthSolutions

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: July 1, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: virtual reality

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No